Trial reportBritish journal of cancer2026
Exposure-response analyses for belantamab mafodotin in combination with bortezomib and dexamethasone in patients with relapsed/refractory multiple myeloma from DREAMM-6 Arm B and DREAMM-7.
Trial report in British journal of cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundBelantamab mafodotin, bortezomib and dexamethasone (BVd) demonstrated clinical activity in the phase I/II DREAMM-6 (Arm B) study and significant clinical benefit in the phase III DREAMM-7 study for patients with relapsed/refractory multiple myeloma (RRMM) and ≥1 prior line of therapy.
methodsPopulation pharmacokinetic-derived Cycle 1 (C1) belantamab mafodotin exposures were used to evaluate exposure-efficacy/exposure-safety relationships across multiple doses and schedules for benefit-risk assessment.
resultsBelantamab mafodotin C1 exposure was positively associated with response endpoints and grade ≥2/ ≥3 ophthalmic exam findings (OEFs), but not grade ≥2/ ≥3 ocular adverse events (oAEs) or best-corrected visual acuity (BCVA) worsening to 20/50 or worse in both eyes. Probability of very good partial response or better (≥VGPR) was higher than grade ≥3 oAEs/BCVA worsening in both eyes across C1 exposures; efficacy improved at higher C1 exposures without increased OEF risk. Model-based benefit-risk assessment showed a belantamab mafodotin starting dose of 1.9 mg/kg instead of 2.5 mg/kg would result in lower probability of ≥VGPR without reduction in BCVA worsening in both eyes/grade ≥3 oAEs.
conclusionsAn initial belantamab mafodotin dose of 2.5 mg/kg for BVd yields deeper responses with minimal change in safety outcomes versus 1.9 mg/kg for patients with RRMM.
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